# Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

> **NCT04598893** · — · ACTIVE_NOT_RECRUITING · sponsor: **Provention Bio, a Sanofi Company** · enrollment: 188 (actual)

## Conditions studied

- Diabetes Mellitus, Type 1

## Interventions

- **BIOLOGICAL:** Teplizumab
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT04598893
- **Lead sponsor:** Provention Bio, a Sanofi Company
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2020-10-26
- **Primary completion:** 2026-11
- **Final completion:** 2026-11
- **Target enrollment:** 188 (ACTUAL)
- **Last updated:** 2025-12-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04598893

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04598893, "Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04598893. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*